NCT03367377

Brief Summary

This study will evaluate the safety and tolerability of LY3209590 when given by injection under the skin to participants with type 2 diabetes. It will also investigate how the body processes the study drug and the effect of the study drug on blood sugar levels. Information about any side effects will be documented. This study will last approximately 17 weeks, not including screening. Screening is required within 4 weeks prior to the start of the study.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P75+ for phase_1 diabetes-mellitus-type-2

Timeline
Completed

Started Jan 2018

Typical duration for phase_1 diabetes-mellitus-type-2

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 5, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 8, 2017

Completed
26 days until next milestone

Study Start

First participant enrolled

January 3, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 3, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 3, 2018

Completed
Last Updated

December 11, 2018

Status Verified

December 1, 2018

Enrollment Period

9 months

First QC Date

December 5, 2017

Last Update Submit

December 10, 2018

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

    A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

    Baseline through 17 weeks

Secondary Outcomes (2)

  • Pharmacokinetics (PK): Area Under the Drug Plasma Concentration Versus Time Curve from Time Zero to 168 hours (AUC[0-168]) of LY3209590

    Week 6

  • Pharmacodynamics (PD): Average Glucose from 7-Point Glucose Profiles

    Baseline, Day 4, Day 40, Day 43

Study Arms (2)

LY3209590

EXPERIMENTAL

Escalating doses of LY3209590 administered by subcutaneous (SC) injection

Drug: LY3209590

Insulin glargine

ACTIVE COMPARATOR

Insulin glargine administered by SC injection

Drug: Insulin Glargine

Interventions

LY3209590DRUG

Administered SC

LY3209590
Insulin GlargineDRUG

Administered SC

Insulin glargine

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants with Type 2 Diabetes Mellitus (T2DM) for at least 1 year
  • Have a glycated hemoglobin (HbA1c) greater than or equal to (≥) 7.0 percent (%) to less than or equal to (≤) 10.5% at screening
  • Have had no episodes of severe hypoglycemia in the past 6 months
  • Are on stable basal insulin (neutral protamine Hagedorn insulin suspension \[NPH\] insulin, insulin glargine \[U100 or U300\], or insulin detemir) with or without metformin, dipeptidyl peptidase IV (DPP-IV) inhibitors, sulfonylureas, and sodium-glucose co-transporter 2 (SGLT-2) inhibitors, at a stable dose for at least 3 months before screening

You may not qualify if:

  • Have significant lipohypertrophy in the target abdominal injection
  • Have a history of renal impairment
  • Have a history of deep vein thrombosis of the leg or repeated episodes of deep leg vein thrombosis in first-degree relatives (parents, siblings, or children)
  • Have proliferative retinopathy or maculopathy and/or severe neuropathy
  • Any significant changes in insulin regimen and/or unstable blood glucose control within the past 3 months prior to screening
  • Require daily insulin treatment less than (\<) 0.15 unit/kilogram (U/kg) per body weight
  • Are treated with a continuous subcutaneous insulin infusion (CSII) pump
  • Currently receiving degludec insulin therapy, or have been treated with degludec within the past 90 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Miami Research Associates

South Miami, Florida, 33143, United States

Location

High Point Clinical Trials Center

High Point, North Carolina, 27265, United States

Location

LMC Endocrinology Centres Ltd.

Toronto, Ontario, M4G 3E8, Canada

Location

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Glargine

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

    Eli Lilly and Company

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2017

First Posted

December 8, 2017

Study Start

January 3, 2018

Primary Completion

October 3, 2018

Study Completion

October 3, 2018

Last Updated

December 11, 2018

Record last verified: 2018-12

Locations

CA(1)US(2)